NAFDAC Warns Nigerians as US Recalls Children’s Ibuprofen Over Contamination

The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted Nigerians to the recall of about 90,000 bottles of Children’s Ibuprofen Oral Suspension in the United States over contamination concerns.

In a public alert on Saturday, NAFDAC said the United States Food and Drug Administration announced the recall after Strides Pharma Inc received consumer complaints of a “gel-like mass” and “black particles” in the oral suspension.

NAFDAC said healthcare providers, importers, distributors, retailers and caregivers should be aware of the recall and follow the USFDA guidance on the affected product.

The agency said caregivers should also check the batch and expiry information on any children’s ibuprofen in their possession and seek advice from a pharmacist before administering the medicine.

Children’s Ibuprofen Oral Suspension, USP, 100 mg per 5 mL, is commonly used to relieve pain associated with the common cold, flu, sore throat, headache and toothache in children, and to reduce fever.

NAFDAC warned that the presence of foreign material in medicinal products could compromise quality, safety and effectiveness, and may cause adverse reactions such as choking or gastrointestinal injury, especially in children.

The agency advised that anyone in possession of the recalled product should stop using it and report concerns to the nearest NAFDAC office or via its official channels.

The affected product is packaged in 120 mL (4 fl. oz.) bottles, and NAFDAC said it would continue to monitor the situation with the USFDA and update Nigerians on any local distribution concerns.

Sources: Premium Times, Daily Post, NewsDirect, Opinion Nigeria, Platform Times